Details for New Drug Application (NDA): 075232
✉ Email this page to a colleague
The generic ingredient in LOPERAMIDE HYDROCHLORIDE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 075232
Tradename: | LOPERAMIDE HYDROCHLORIDE |
Applicant: | L Perrigo Co |
Ingredient: | loperamide hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075232
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 075232
Suppliers and Packaging for NDA: 075232
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | TABLET;ORAL | 075232 | ANDA | L. Perrigo Company | 0113-0224 | 0113-0224-53 | 12 BLISTER PACK in 1 CARTON (0113-0224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | TABLET;ORAL | 075232 | ANDA | L. Perrigo Company | 0113-0224 | 0113-0224-62 | 24 BLISTER PACK in 1 CARTON (0113-0224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Jan 6, 2000 | TE: | RLD: | No |
Complete Access Available with Subscription